Sub-symptom Threshold Aerobic Exercise After Mild Traumatic Brain Injury

NCT ID: NCT05086419

Last Updated: 2025-08-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2025-11-30

Brief Summary

This Randomized Controlled Trial (RCT) will explore the effect of sub-symptom threshold aerobic exercise on persistent post-concussion symptoms and exercise intolerance in patients with mild Traumatic Brain Injury (TBI). The hypothesis is that sub-symptom training will reduce the symptom pressure, normalize exercise tolerance, reduce patient-specific activity limitations and improve health-related quality of life. To improve the chances of conducting a high-quality RCT, a feasibility trial will be completed prior to the definitive RCT.

Detailed Description

Background: Persistent post-commotio symptoms (PCS) affect between 34% and 46% of individuals after a mild traumatic brain injury (TBI). Many also experience exercise intolerance. Sub-symptom threshold aerobic exercise (exercise at an intensity level that does not increase symptoms) is proposed as treatment both to increase the exercise tolerance and to ease the symptom burden after the injury.

Main purpose: The main purpose of this study is to evaluate whether a progressive sub-symptom threshold exercise program in addition to ordinary rehabilitation will lead to clinically meaningful improvement of symptom burden, normalize exercise tolerance, increase physical activity, improve health-related quality of life, and reduce patient-specific activity limitations compared to a control group that only receives ordinary rehabilitation.

Design: Randomized, controlled, single-blind parallel-group study with three measurement times; T0 at baseline, T1 after the intervention and T2 six months after T1.

Method: 68 patients between the ages of 18 and 60 with exercise intolerance and persistent PCS will be recruited to the study and randomized to two groups. All participants will receive ordinary rehabilitation. The intervention group will in addition receive sub-symptom threshold aerobic exercise for 12 weeks with weekly follow-up by a physiotherapist and a retest every 3 weeks for optimal dosage and progression. Rivermead post-concussion symptoms questionnaire (RPQ) will be the main outcome measure. The secondary outcome measure will be a test of exercise tolerance - the Buffalo Concussion Treadmill Test (BCTT). Other outcome measures include the patient-specific functional scale that measures patient-specific activity limitations, as well as outcome measures for health-related quality of life, anxiety and depression, specific symptoms such as dizziness, headache and fatigue, and level of physical activity.

Clinical relevance: Since people with persistent symptoms after mild TBI often have reduced level of functioning and difficulty working / studying full time, there is a great need for an individually tailored intervention that has the potential to reduce persistent symptoms and improve functioning This project will increase the evidence based knowledge about the effect of sub-symptom threshold aerobic exercise in patient with persistent symptoms after mild TBI.

Conditions

Mild Traumatic Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Exercise group

The exercise group will in addition to treatment as usual, receive sub-symptom threshold aerobic exercise for approx. 30 minutes 3-5x / week for 12 weeks. Sub-symptom threshold aerobic exercise is based on the individual patient's symptom threshold and will be between 80-90% of the maximum heart rate achieved during testing/BCTT. To ensure proper exercise dosage and progression, participants will be retested every 3 weeks. An experienced doctor and / or physiotherapist will carry out the testing and guide the participants in the content and dosage (duration, intensity, and frequency) of the sub-symptom threshold aerobic exercise/intervention.

Group Type: EXPERIMENTAL

Sub-symptom threshold aerobic exercise

Intervention Type: OTHER

For the first three weeks, participants will be offered guided sub-symptom threshold aerobic exercise on a treadmill or exercise bike once a week. The remaining 2-4 sub-symptom threshold aerobic exercise workouts per. week will be on their own. Location and mode of exercise (treadmill, walking, jogging, exercise bike / bicycle, swimming, or elliptical machine) will be individually adapted to the patients experience, preferences and opportunities. The intensity of the sub-symptom threshold aerobic exercise will always be monitored using a heart rate monitor and/or ratings of perceived exertion (Borg RPE). If there still is a need for closer follow-up after the first three weeks, a physiotherapist in primary health care service will be involved under supervision from a physiotherapist (research fellow) in the project.

Treatment as usual group

The treatment as usual group will receive assessment and treatment provided by a multidisciplinary outpatient rehabilitation team. Patients will undergo a medical examination and assessment of physical, cognitive and mental health and functioning, followed by individually adapted rehabilitation. The interdisciplinary team consists of a specialist in physical medicine and rehabilitation, neuropsychologist, occupational therapist, physiotherapist, and social worker. The main focus is on stabilizing the level of function in everyday life and gradual return to work and education.

Participants receive general advice on physical activity based on recommendations from the Norwegian Directorate of Health, but not specific guidance in sub-symptom threshold aerobic exercise and help with exercise dosage (frequency, duration and intensity).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Sub-symptom threshold aerobic exercise

For the first three weeks, participants will be offered guided sub-symptom threshold aerobic exercise on a treadmill or exercise bike once a week. The remaining 2-4 sub-symptom threshold aerobic exercise workouts per. week will be on their own. Location and mode of exercise (treadmill, walking, jogging, exercise bike / bicycle, swimming, or elliptical machine) will be individually adapted to the patients experience, preferences and opportunities. The intensity of the sub-symptom threshold aerobic exercise will always be monitored using a heart rate monitor and/or ratings of perceived exertion (Borg RPE). If there still is a need for closer follow-up after the first three weeks, a physiotherapist in primary health care service will be involved under supervision from a physiotherapist (research fellow) in the project.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients with mild TBI defined by the World Health Organization (WHO) Collaborating Center Task Force definition: 1) one or more of the following: confusion or disorientation, loss of consciousness (LOC) ≤30 minutes, post-traumatic memory loss (PTA) ≤24 hours and / or transient neurological focal deficits and intracranial lesions that do not require surgery; 2) Glasgow Coma Scale (GCS) score of 13-15 at least 30 minutes after trauma).
• 18-60 years with persistent post-commotio symptoms (minimum 3 months maximum 2 years).
• Reduced tolerance to physical activity/exercise intolerance (self-reported worsening of symptoms such as dizziness and headache during physical activity and exercise).

Exclusion Criteria

• Other neurological or psychiatric conditions (not including anxiety and depression) listed in the medical record. Heart-lung disease, extremity injuries that prevent physical exercise, drug addiction and insufficient understanding of the Norwegian language (unable to follow instructions and/or fill in forms). Normal BCTT.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ingerid Kleffelgård

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ingerid Kleffelgård, Phd

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

Oslo University Hospital

Oslo, , Norway

Countries

Norway

References

Valaas LV, Soberg HL, Rasmussen MS, Steenstrup SE, Andelic N, Kleffelgard I. Sub-symptom threshold aerobic exercise for patients with persisting post-concussion symptoms and exercise intolerance after mild traumatic brain injury - a study protocol with a nested feasibility study for a randomized controlled trial. BMC Neurol. 2023 May 3;23(1):179. doi: 10.1186/s12883-023-03221-7.

Reference Type: DERIVED

PMID: 37138202 (View on PubMed)

Other Identifiers

REK #256109

Identifier Type: -

Identifier Source: org_study_id